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GEN1106 for Solid Tumors

This study is testing a new treatment called GEN1106 for people with certain solid tumors, including urothelial carcinoma (a type of bladder cancer). You might be able to join if your cancer has progressed after standard treatments, or if there are no other standard treatments available. The main goals are to find a safe dose of GEN1106 and see how well it works. The study will look at side effects and how your body responds to the treatment. The total time you would be in the study is about 17 months, but this can vary.

Study design
This is an open-label study, meaning both you and your doctors will know you are receiving GEN1106. It will involve about 103 participants and has different parts to find the best dose and then test its effectiveness.
What's involved
You will receive GEN1106 through an intravenous (IV) infusion. The study will involve monitoring for side effects and how your body responds to the treatment for up to approximately 16 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) and serious adverse events for up to approximately 16 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07416123

A Study of GEN1106 in Participants With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Genmab
~103 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:GEN1106

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
Measured over 21 days
+3 more outcomes measured

Conditions

Solid Tumors
Urothelial Carcinoma

Explore related trials

Solid NeoplasmUrothelial Carcinoma

Where it's being run

10 sites across 7 states
Spain4
Connecticut1
New York1
South Carolina1
Tennessee1
Texas1
Tokyo1

Study leadership

  • Study Official · STUDY_DIRECTOR · Genmab

Who to contact

Genmab Trial Information
[email protected]
+4570202728
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and/or quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable.
Have measurable disease according to RECIST v1.1.
Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.
Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.
Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).

Exclusion

Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.
Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.

What this trial measures

  • Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)21 days
  • Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to approximately 16 months
  • Part 2 Dose Refinement: Number of Participants with AEs and SAEsUp to approximately 16 months
  • Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Up to approximately 16 months